Hospitalised Pneumonia With Extended Treatment (HOPE) Study

NCT02783859 | Completed Phase 4 DMC

• 1 other identifier: HOPE_V5_01022017
• Study Type: interventional
• Target: 314
• Locations: 3 countries
• Sites: 5

Brief Summary

An intervention study to determine if a longer duration of antibiotics (compared to shorter duration) improves the short and long term clinical outcomes of children hospitalised for pneumonia

Conditions

Pneumonia

Keywords

Children; Anti-Bacterial Agents; Indigenous Population; Hospitals

Outcome Measures

Primary Outcomes (1)

• The proportion without chronic respiratory symptoms and signs or bronchiectasis.

  Any further chronic respiratory symptoms and signs or bronchiectasis though the child's medical records (community or hospital) will be captured. These children will be reviewed at 24 months, however many children will reside in geographically isolated locations, thus a range of 23-25 months is a reasonable timeframe to capture clinically important outcomes.

  Clinical review at 24 months (range 23-25 months)

Secondary Outcomes (5)

• The proportion with clinical cure (i.e. complete resolution of respiratory symptoms and signs).

  Clinical review week 4 (range 4-6 weeks)

• Time to next respiratory-related hospitalisation assessed by chart reviews

  Clinical review week 4 (range 4-6 weeks)

• Adverse events

  Adverse events monitored while participant taking trial medication

• Nasopharyngeal bacteria antibiotic resistance patterns

  Baseline (admission to hospital, week 4 (range 4-6 weeks) and 12 months (range 12-14 months)

• Gene expression data

  Baseline (hospital admission) and 4-6 weeks (where possible)

Study Arms (2)

Active arm: Amoxicillin-clavulanic Acid

EXPERIMENTAL

8 days of oral amoxicillin-clavulanic Acid 400/57 duo formulation (70-90mg/kg/day, twice daily dosing: max 980mg per day)

Drug: Amoxicillin-clavulanic Acid

Placebo arm

PLACEBO COMPARATOR

8 days of oral placebo (equivalent volume as the active arm)

Drug: Placebo (for Amoxicillin-clavulanic Acid)

Interventions

Amoxicillin-clavulanic Acid DRUG

Active arm: Amoxicillin-clavulanic Acid

Placebo (for Amoxicillin-clavulanic Acid) DRUG

Placebo arm

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Hospitalised children aged 3-mo to 5-yrs (in Darwin, children have to be Indigenous)
• Have features of severe pneumonia on admission (temperature \>37.5 celsius or a history of fever at home or observed at the referring clinic, age-adjusted tachypnoea \[respiratory rate\>50 if \<12-months; respiratory rate\>40 if \>12-months\] with chest wall recession and/or oxygen saturation \<92% in air), and consolidation on chest X-ray as diagnosed by treating clinician
• After 1-3 days of IV antibiotics, are afebrile, with improved respiratory symptoms and signs, oxygen saturation\>90% in air and are ready to be switched to oral amoxicillin-clavulanate, and
• Have symptoms of no longer than 7 days at point of hospitalisation.

You may not qualify if:

• Current wheeze
• Underlying chronic illness other than asthma (e.g. bronchiectasis, cyanotic congenital heart disease or cardiac failure, neuromuscular disorders, immunodeficiency) that could potentially influence the current illness
• Severe malnutrition (weight-for-height Z-score \<-3)
• Complicated (effusion, empyema or abscess) pneumonia, including tuberculosis
• Extra-pulmonary infection requiring antibiotic therapy (e.g. meningitis)
• Beta-lactam allergy
• Previously enrolled
• Lack a mobile phone and/or unable to return for follow-up clinic visits during the next 24 months

Sponsors & Collaborators

• The University of Queensland: collaborator
• Queensland University of Technology: collaborator
• Nanyang Technological University: collaborator
• Menzies School of Health Research: lead
• Griffith University: collaborator
• Sarawak General Hospital: collaborator
• University of Malaya: collaborator

Study Sites (5)

Menzies School of Health Research

Darwin, Northern Territory, 0812, Australia

Location

University Malaya Medical Centre and Klang Hospital

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

Location

Sabah Women and Children's Hospital

Kota Kinabalu, Sabah, 88996, Malaysia

Location

Sarawak General Hospital

Sibu, Sarawak, 96000, Malaysia

Location

Starship Children's Hospital & KidzFirst Hospital

Auckland, Auckland, 1142, New Zealand

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Organic Chemicals; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Anne Chang, PhD

  Menzies School of Health Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: May 26, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3); AU (1); NZ (1)